Transdermal Continuous Oxygen Therapy for Diabetic Foot Ulcers

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Ogenix Corporation
ClinicalTrials.gov Identifier:
NCT01291160
First received: February 4, 2011
Last updated: April 11, 2014
Last verified: April 2014
Results First Received: April 11, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Double Blind (Subject, Caregiver, Investigator);   Primary Purpose: Treatment
Condition: Diabetic Foot Ulcers
Interventions: Device: Epiflo
Other: Moist Wound Therapy

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
No text entered.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Epiflo Treatment

The cohort will comprise of 2 populations: the Treatment Arm of up to 90 subjects; and the Control Arm of up to 90 subjects, in order to collect 120 invaluable subjects. The Treatment Arm includes subjects with DFU who will receive EPIFLO in addition to standard wound care therapy during the Treatment Period.

Epiflo: During the Treatment Period, subjects will be administered EPIFLO (either working units or sham units per randomization schedule) in conjunction with standard wound therapy regimen consisting of aggressive debridement, wound cleansing, wound dressing, for a period of 12 weeks, or until the wound completely closes, whichever event occurs first.

Sham Device

The cohort will comprise of 2 populations: the Treatment Arm of up to 90 subjects; and the Control Arm of up to 90 subjects, in order to collect 120 invaluable subjects. Control Arm includes subjects with Diabetic Foot Ulcers who will receive sham units of EPIFLO along with standard wound care therapy during the treatment Period.

Moist Wound Therapy: During the Treatment Period, subjects will be administered EPIFLO (either working units or sham units per randomization schedule) in conjunction with standard wound therapy regimen consisting of aggressive debridement, wound cleansing, wound dressing, for a period of 12 weeks, or until the wound completely closes, whichever event occurs first.


Participant Flow:   Overall Study
    Epiflo Treatment     Sham Device  
STARTED     66     64  
COMPLETED     48     48  
NOT COMPLETED     18     16  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Epiflo Treatment

The cohort will comprise of 2 populations: the Treatment Arm of up to 90 subjects; and the Control Arm of up to 90 subjects, in order to collect 120 invaluable subjects. The Treatment Arm includes subjects with DFU who will receive EPIFLO in addition to standard wound care therapy during the Treatment Period.

Epiflo: During the Treatment Period, subjects will be administered EPIFLO (either working units or sham units per randomization schedule) in conjunction with standard wound therapy regimen consisting of aggressive debridement, wound cleansing, wound dressing, for a period of 12 weeks, or until the wound completely closes, whichever event occurs first.

Sham Device

The cohort will comprise of 2 populations: the Treatment Arm of up to 90 subjects; and the Control Arm of up to 90 subjects, in order to collect 120 invaluable subjects. Control Arm includes subjects with Diabetic Foot Ulcers who will receive sham units of EPIFLO along with standard wound care therapy during the treatment Period.

Moist Wound Therapy: During the Treatment Period, subjects will be administered EPIFLO (either working units or sham units per randomization schedule) in conjunction with standard wound therapy regimen consisting of aggressive debridement, wound cleansing, wound dressing, for a period of 12 weeks, or until the wound completely closes, whichever event occurs first.

Total Total of all reporting groups

Baseline Measures
    Epiflo Treatment     Sham Device     Total  
Number of Participants  
[units: participants]
  66     64     130  
Age  
[units: years]
Mean ± Standard Deviation
  59.25  ± 13.06     58.46  ± 9.53     59.25  ± 13.06  
Age  
[units: participants]
     
<=18 years     0     0     0  
Between 18 and 65 years     47     47     94  
>=65 years     19     17     36  
Gender  
[units: participants]
     
Female     21     15     36  
Male     45     49     94  



  Outcome Measures

1.  Primary:   Number of 100% Wound Closure   [ Time Frame: before or at week 12 ]
  Hide Outcome Measure 1

Measure Type Primary
Measure Title Number of 100% Wound Closure
Measure Description No text entered.
Time Frame before or at week 12  
Safety Issue No  

Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Analyzed the per-protocol population

Reporting Groups
  Description
Epiflo Treatment

The cohort will comprise of 2 populations: the Treatment Arm of up to 90 subjects; and the Control Arm of up to 90 subjects, in order to collect 120 invaluable subjects. The Treatment Arm includes subjects with DFU who will receive EPIFLO in addition to standard wound care therapy during the Treatment Period.

Epiflo: During the Treatment Period, subjects will be administered EPIFLO (either working units or sham units per randomization schedule) in conjunction with standard wound therapy regimen consisting of aggressive debridement, wound cleansing, wound dressing, for a period of 12 weeks, or until the wound completely closes, whichever event occurs first.

Sham Device

The cohort will comprise of 2 populations: the Treatment Arm of up to 90 subjects; and the Control Arm of up to 90 subjects, in order to collect 120 invaluable subjects. Control Arm includes subjects with Diabetic Foot Ulcers who will receive sham units of EPIFLO along with standard wound care therapy during the treatment Period.

Moist Wound Therapy: During the Treatment Period, subjects will be administered EPIFLO (either working units or sham units per randomization schedule) in conjunction with standard wound therapy regimen consisting of aggressive debridement, wound cleansing, wound dressing, for a period of 12 weeks, or until the wound completely closes, whichever event occurs first.


Measured Values
    Epiflo Treatment     Sham Device  
Number of Participants Analyzed  
[units: participants]
  61     61  
Number of 100% Wound Closure  
[units: percentage¬†of¬†patients]
  55.74     50.82  

No statistical analysis provided for Number of 100% Wound Closure




  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: S.Sarangapani
Organization: Ogenix
phone: 7817026732
e-mail: ssarangapani@ogenix.com


No publications provided


Responsible Party: Ogenix Corporation
ClinicalTrials.gov Identifier: NCT01291160     History of Changes
Other Study ID Numbers: EPF-409
Study First Received: February 4, 2011
Results First Received: April 11, 2014
Last Updated: April 11, 2014
Health Authority: United States: Food and Drug Administration